Alterations in Cognitive Function and Cerebral Blood Flow After Conversion From Calcineurin Inhibitors (CNIs) to Everolimus

October 18, 2024 updated by: Aditi Gupta, MD, University of Kansas Medical Center

Alterations in Cognitive Function and Cerebral Blood Flow After Conversion From Calcineurin Inhibitors to Everolimus

The purpose of this study is to learn if changing from Tacrolimus to Everolimus will improve cognitive function by having less effect on brain blood flow.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Potential participants will be patients undergoing kidney transplant at the University of Kansas Medical Center.

Description

Inclusion Criteria:

  • English speaking
  • able to sign informed consent
  • able to arrange transportation to and from study site
  • without acute stroke, concussion or traumatic brain injury
  • without acute medical issues at the time of participation
  • At least 12 weeks post Kidney transplant surgery

Exclusion Criteria:

  • are claustrophobic or have other contra-indication for magnetic resonance imaging (MRI)
  • have hearing or visual impairment
  • are unable to read, write, speak or understand English
  • have uncontrolled psychosis or seizure disorder or are currently using antipsychotics or anti-epileptics
  • taking Envarsus at the time of recruitment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Conversion Group
Kidney transplant recipients at the University of Kansas Medical Center (KUMC) who are currently on tacrolimus (CNI), and will be undergoing conversion to Everolimus + low dose CNI. Potential participants will be asked to participate in the study after the decision to convert CNI to Everolimus + low dose CNI has been made.
Drug: Tacrolimus
The patient's physician will prescribe drug according to standard practice.
Other Names:
  • Prograf
Drug: Everolimus
The patient's physician will prescribe drug according to standard practice.
Control Group
Kidney transplant recipients at KUMC on tacrolimus (CNI). These will be patients not planning to undergo any change in immunosuppression.
Drug: Tacrolimus
The patient's physician will prescribe drug according to standard practice.
Other Names:
  • Prograf

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in cognitive function
Time Frame: Change from Baseline to Week 12
Change from Baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in cerebral blood flow
Time Frame: Change from Baseline to Week 12
Change from Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Collaborators

Novartis Pharmaceuticals

Investigators

  • Principal Investigator: Aditi Gupta, MD, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2018

Primary Completion (Actual)

August 1, 2021

Study Completion (Actual)

October 1, 2022

Study Registration Dates

First Submitted

January 22, 2018

First Submitted That Met QC Criteria

January 22, 2018

First Posted (Actual)

January 29, 2018

Study Record Updates

Last Update Posted (Actual)

October 22, 2024

Last Update Submitted That Met QC Criteria

October 18, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00140594
  • CRAD001AUS211T (Other Grant/Funding Number: Novartis Pharmaceuticals)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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